services > Drug Delivery Consulting Services

Drug Delivery Consulting Services

In addition to providing specific drug delivery technology solutions to therapeutic candidates with known dissolution, permeability and/or presystemic clearance limitations, TSRL also provides consulting and problem solving services to clients who seek to identify the mechanism of the poor oral bioavailability of a drug candidate. Within this scope, TSRL has carved out a niche service by classifying client drugs according to the Biopharmaceutics Classification System (BCS), which is an international drug regulation that allows for waiving of clinical bioequivalence trials for drugs in certain BCS classes after drug product manufacturing changes. This may translate into substantial development cost savings for clients.

Characterize the Issues
- API/Drug Product:
  - Solubility
  - Dissolution
  - Stability
- In vitro / in vivo performance:
  - Permeability classification (BCS)
  - Site specific permeability (duodenal, jejunal, ileal, and colonic)
  - Full PK/Bio
  - Metabolism
  - Exploratory toxicology
- PK Modeling & Simulations
  - (Non)-compartmental PK modeling
  - Intestinal Absorption Modeling (Gastro Plus)
Propose Delivery Solution

Solubility enhancement
Permeability enhancement
Prodrug approach
Time and rate controlled release technologies

Early Development Partners

Formulation scale-up
Long term stability
Toxicology
Phase I – Pharmacokinetic POC